Mimpara 30 mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Mimpara is and what it is used for
2. What you need to know before you take Mimpara
3. How to take Mimpara
4. Possible side effects
5. How to store Mimpara
6. Contents of the pack and other information

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Mimpara.

Before you start taking Mimpara, tell your doctor if you have or have ever had:

• seizures (fits or convulsions). The risk of having seizures is higher if you have had them before;
• liver problems;
• heart failure.

Mimpara reduces calcium levels. Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with Mimpara.

Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Mimpara.

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Mimpara.

For additional information see section 4.

During treatment with Mimpara, tell your doctor:

• if you start or stop smoking, as this may affect the way Mimpara works.

Children and adolescents

Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Mimpara.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Mimpara and during treatment with Mimpara. You should inform your doctor if you experience any of the signs of low calcium levels as described above.

It is important that you take your dose of Mimpara as advised by your doctor.

Other medicines and Mimpara

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.

You should not receive Mimpara together with etelcalcetide.

Tell your doctor if you are taking the following medicines

Medicines such as these can affect how Mimpara works:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin);
• a medicine used to treat HIV infection and AIDS (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Mimpara may affect how medicines such as the following work:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);
• a medicine used to relieve cough (dextromethorphan);
• medicines used to treat changes in heart rate (flecainide and propafenone);
• a medicine used to treat high blood pressure (metoprolol).

Mimpara with food and drink

Mimpara should be taken with or shortly after food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Mimpara has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.

It is not known whether Mimpara is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.

Driving and using machines

Dizziness and seizures have been reported by patients taking Mimpara. If you experience these side effects, do not drive or operate machines.

Mimpara contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you take more Mimpara than you should

If you take more Mimpara than you should you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.

If you forget to take Mimpara

Do not take a double dose to make up for a forgotten dose.

If you have forgotten a dose of Mimpara, you should take your next dose as normal.

Please tell your doctor immediately:

• If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures These may be signs that your calcium levels are too low (hypocalcaemia).
• If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting, these side effects are normally quite mild and do not last for long.

Common: may affect up to 1 in 10 people

• dizziness
• numbness or tingling sensation (paraesthesia)
• loss (anorexia) or decrease of appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• reduced testosterone levels
• high potassium levels in the blood (hyperkalaemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (convulsions or fits)
• low blood pressure (hypotension)
• upper respiratory infection
• breathing difficulties (dyspnoea)
• cough
• indigestion (dyspepsia)
• diarrhoea
• abdominal pain, abdominal pain – upper
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcaemia).

Not known: frequency cannot be estimated from available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).

After taking Mimpara a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

Malta

What Mimpara contains

• The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
• The other ingredients are:
  • Pre-gelatinised maize starch
  • Microcrystalline cellulose
  • Povidone
  • Crospovidone
  • Magnesium stearate
  • Colloidal anhydrous silica
• The tablets are coated with:
  • Carnauba wax
  • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
  • Opadry clear (containing hypromellose, macrogol)

What Mimpara looks like and contents of the pack

Mimpara is a light green film-coated tablet. They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.

30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.

60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.

90 mg tablets are approximately 13.9 mm long and 8.7 mm wide.

Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28 or 84 tablets in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.